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Soy Protein/Effexor Hormone Therapy for Prostate Cancer

This study has been terminated.
(Stopped by the DSMB for lack of effect per interim stopping rule.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354432
First Posted: July 20, 2006
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes.

PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.


Condition Intervention Phase
Hot Flashes Prostate Cancer Dietary Supplement: oral soy protein/isoflavones powder Drug: Venlafaxine Dietary Supplement: Placebo Powder Drug: Placebo Pill Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Hot Flash Symptom Severity Score [ Time Frame: 12 weeks ]
    The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 12 weeks ]
    Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.


Enrollment: 120
Study Start Date: February 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I - Placebo
Patients receive oral placebo pill and oral placebo powder once daily.
Dietary Supplement: Placebo Powder
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Other Name: Casein
Drug: Placebo Pill
Patients receive oral placebo pill.
Other Name: Sugar Pill
Active Comparator: Arm II - Soy
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
Dietary Supplement: oral soy protein/isoflavones powder
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
Other Names:
  • Protein powder
  • Supplement powder soy and casein 20gm
  • Isoflavones
  • Isocaloric supplement
  • Casein protein
Drug: Placebo Pill
Patients receive oral placebo pill.
Other Name: Sugar Pill
Experimental: Arm III - Venlafaxine
Patients receive oral Venlafaxine pill and placebo powder once daily.
Drug: Venlafaxine
Patients receive oral venlafaxine 75mg.
Other Names:
  • Effexor XR
  • placebo
Dietary Supplement: Placebo Powder
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Other Name: Casein
Placebo Comparator: Arm IV - Soy + Venlafaxine
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Dietary Supplement: oral soy protein/isoflavones powder
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
Other Names:
  • Protein powder
  • Supplement powder soy and casein 20gm
  • Isoflavones
  • Isocaloric supplement
  • Casein protein
Drug: Venlafaxine
Patients receive oral venlafaxine 75mg.
Other Names:
  • Effexor XR
  • placebo

Detailed Description:

OBJECTIVES:

Primary

  • Assess the effect of soy protein/isoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer.

Secondary

  • Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of these patients.
  • Monitor and assess the participant drop out rate.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to severity of disease (metastatic vs nonmetastatic) and baseline severity of hot flashes. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
  • Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.
  • Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.
  • Arm IV: Patients receive oral placebo pill and oral placebo powder once daily. Treatment in all arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks of treatment, patients in arms I and III receive a tapered dose of oral venlafaxine once daily for 1 week.

Patients complete a vasomotor symptom diary once daily beginning 7 days before the initiation of study treatment and continuing until the completion of study treatment. Quality of life is assessed at baseline and at week 12.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of prostate cancer, any stage Life expectancy of > nine months
  • Prior or current androgen deprivation for treatment or control of prostate cancer to include:
  • Bilateral Orchiectomy
  • LHRH agonist (with or without antiandrogen therapy) ie: leuprolide (Lupron), goserelin (Zoladex), bicalutamide (Casodex), flutamide (Eulexin), or similar agents
  • Chemotherapy
  • Radiation (Patients may undergo concurrent radiation therapy to the prostate, prostate + seminal vesicles, and/or pelvis). Seed implants are allowed
  • Participant report of hot flash frequency of an average of four or more per day, as defined by sweating, flushing, sensation of warmth, night sweats (Average of 28 per week)
  • Hot flashes must be moderate or severe (See appendix A for hot flash definitions)
  • Grade 2 (Moderate flashes) are warmer, produce obvious perspiration, and last 2 to 3 minutes
  • Grade 3 (Severe flashes) causes profuse perspiration, generate intense heat, last longer and interfere with ongoing activity
  • Age >21
  • No allergies to soy or dairy products
  • No current use of SSRIs, SNRI's, MAOIs, or Linezolide
  • No uncontrolled hypertension (160/90) or greater than Class I American Heart Association functional capacity
  • No history of mania, hypomania, bipolar disorder, or anorexia nervosa
  • No history of seizures
  • No history of hepatic dysfunction)
  • Must have a telephone
  • Signed protocol-specific Informed Consent
  • Participants consuming soy foods or soy based supplements must continue on a stable regimen during study participation
  • Patients should maintain same treatment and medications for prostate cancer throughout entire study.
  • No change in treatment for 2 weeks prior to registration.
  • Current use of medications and herbal supplements for hot flashes are allowed if on a stable regimen throughout the entire study. (Does not include anti-depressants)

Exclusion Criteria:

  • Anticipated changes in prostate cancer treatment plan (i.e., hormonal manipulation, changes in chemotherapy)
  • Concurrent antidepressant therapy
  • History of intolerance to venlafaxine
  • Recent (within 14 days) use of venlafaxine (Effexor XRTM), monoamine oxidase inhibitor, SSRI (selective serotonin reuptake inhibitor), or SNRI (selective norepinephrine reuptake inhibitor)
  • History of seizure disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354432


Locations
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Illinois
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States, 60612
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
United States, Missouri
CCOP - Heartland Research Consortium
Saint Louis, Missouri, United States, 63131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
United States, North Carolina
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States, 27534
Caldwell Memorial Hospital
Lenoir, North Carolina, United States, 28645
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Wake Forest University CCOP Research Base
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Cancer Centers of the Carolinas - Easley
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Mara Vitolins, DrPH, RD Wake Forest University Health Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00354432     History of Changes
Other Study ID Numbers: REBAcccwfu97405
U10CA081851 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: July 15, 2015
Results First Posted: May 18, 2017
Last Update Posted: June 20, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
hot flashes

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Hot Flashes
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Venlafaxine Hydrochloride
Caseins
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Chelating Agents
Sequestering Agents


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